On 25 August 2016, EU released Regulation (EU) 2016/1416 to amend Regulation (EU) 10/2011 on plastic materials and articles that intended to come into direct contact with food as regards specific migration limits of heavy metals, union list of authorised substances, test methods for overall and specific migration.
Since the Regulation's adoption, the European Food Safety Authority (‘the Authority’) has published further reports on particular substances that may be used in food contact materials as well as on the permitted use of substances that have been authorised previously. In addition, certain textual errors and ambiguities were identified. In order to ensure that the Regulation reflects the most recent findings of the Authority and in order to remove any doubt as regards its correct application, the Regulation should be amended and corrected.
Revisions on limits
1. | Adjust union list of some authorised substances under Annex I Add requirements on FCM Nos. 871, 1031, 1034, 1045, 1046, 1048, 1050, 1051, 1052, 1053 |
2. | Revise specific migration limits (SMLs) Aluminium = 1 mg/kg food or food stimulant (new) Zinc = 5 mg/kg food or food simulant. (previous: 25 mg/kg) |
3. | Amend primary aromatic amines Primary aromatic amines which are not listed in Table 1 of Annex I shall not migrate or shall not otherwise be released from plastic materials and articles into food or food simulant in accordance with Article 11(4). The detection limit (0,01 mg/kg) referred to in the second subparagraph of Article 11(4) applies to the sum of primary aromatic amines released. |
4 | Delete the provision“For substances for which no specific migration limit or other restrictions are provided in Annex I, a generic specific migration limit of 60 mg/kg shall apply.”in Annex I. |
Revisions on selection of testing conditions
1. | Revise conditions for food simulants For food simulant D2, the food stimulant has been changed as “Any vegetable oil containing less than 1 % unsaponifiable matter” |
2. | Some food simulants are changed Since the Regulation distinguishes between food simulants D1 and D2, the references to food simulant D should be replaced by more specific references to food simulant D1 or D2 for all substances. |
3. | New selections of test temperatures New requirements for 175℃ |
4 | Amend testing conditions of overall migration (OM2, OM3) A definition of the term ‘hot-fill’ is provided to specify the temperatures at which such restrictions apply. t2 =t1 * Exp (9627 * (1/T2 – 1/T1)) |
This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.
Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, may be placed on the market until 14 September 2017 and may remain on the market until exhaustion of stocks. The provisions on the specific migration limits for aluminium and for zinc set out in point 2(a) of the Annex and the assignments of food simulants in point 3(c) of the Annex shall apply from 14 September 2018. C&K Testing advises businesses to deal with due care.
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